Accelerated Pathways & Commercial Consequences Forum & Findings

By Barry Farrimond

June 3, 2016

For two days in the last week of October 2015, PAREXEL and the Network for Excellence in Health Innovation (NEHI) hosted an executive forum in Boston, Massachusetts that was attended by over 80 companies from small biotechs to top ten pharma. Guests travelled from as far away as Pasadena, CA, for a program that included presentations of original research findings (including that from a U.S. payer survey) and perspectives from an array of industry experts on the consequences of accelerated development. The goal of the event, which will be held in similar form in London on 12 July 2016, was to facilitate a discussion on how accelerated pathways (APs) are impacting drug development, approval, reimbursement, and access.

The forum presented the FDA’s various accelerated pathways as the new normal in the drug development process – according to the FDA’s annual report, two-thirds of novel drugs approved in 2015 used at least one AP, while a third used two or more. These pathways offer plenty of good news for payers and developers: shortened clinical development times, effective drugs getting to patients faster, products widely reimbursed by U.S. payers, and premium pricing for value. But APs also carry risks. For payers, initial pricing and coverage decisions need to be tested against real-world evidence. For developers, the trend toward formal value-based assessments looks unstoppable.

Explore below the specific findings and articles from the forum in greater detail.